SODIUM BENZOATE
화장품에서 소듐벤조에이트 (SODIUM BENZOATE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?
소듐벤조에이트(표준 INCI: SODIUM BENZOATE, CAS 번호: 532-32-1)은 화장품 처방에서 주로 향료, 방부제, 부식방지제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(제한) 및 유럽 CosIng(제한) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.15–1%(적정 pH 3.5–5.2) 범위에서 안정적으로 처방됩니다.
7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스
각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건| 국가·규제 트랙 | 공식 고시 전성분 표기명 | 원클릭 복사 |
|---|---|---|
| ① 한국 (MFDS 화장품 한글 표준명) | 소듐벤조에이트 | |
| ② 한국 구명칭 (개정 전 이력 · 301 리다이렉트) | — | — |
| ③ 유럽 (EU CosIng EC 1223/2009) | SODIUM BENZOATE | |
| ④ 미국 일반화장품 (US PCPC / MoCRA INCI) | SODIUM BENZOATE | |
| ⑤ 미국 OTC (FDA Active Ingredient Monograph) | — (비-OTC 일반 화장품 원료) | — |
| ⑥ 중국 (NMPA IECIC 표준 중문명) | 苯甲酸钠 | |
| ⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW) | 安息香酸Na · [QD: 安息香酸ナトリウム] |
Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태
| 권역 | 규제 상태 | 배합 한도 | 제한 조건 및 1차 법원 출처 |
|---|---|---|---|
| 한국 (MFDS) | 제한 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 유럽 (CosIng) | 제한 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 미국 (FDA/CIR) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 중국 (NMPA) | 제한 | GMP | IECIC Entry #1289 |
| 일본 (MHLW) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 아세안 (ACD) | 제한 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
Layer 2 — 독성·안전성 평가 한도 (US CIR · EU SCCS MoS≥100 · CN IECIC 최고역사사용량)
「SCCS 안전 판정 상한」은 유럽 소비자안전과학위원회가 안전역(MoS≥100)으로 판정한 상한이며, 「CIR 시판 보고 농도」와 「중국 IECIC 최고역사사용량」은 실제 시판 제품에 보고된 최대 농도입니다.
| 안전성 평가 기준 | 적용 부위·유형 | 안전 농도 범위 | 판정 결과 및 문헌 번호 |
|---|---|---|---|
| CIR 시판 보고 농도 | eye | 0.00001~0.4% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | ingestion | 0.001~0.6% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | spray | 0.0001~0.5% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | dermal | 0.000001~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | deodorant | 0.5~0.5% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | hair | 0.000005~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | hair_dye | 0.008~0.5% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | nail | 0.00001~0.001% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | mucous | 0.0004~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | bath | 0.004~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | baby | 0.3~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | leave_on | 0.000001~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | rinse_off | 0.000001~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | total | 0.000001~1% | 안전 판정(MoS≥100)119_draft_benzyl.pdf () |
| CIR 시판 보고 농도 | powder | 0.3~0.3% | 안전 판정(MoS≥100)120_final_ba.pdf () |
| 중국 IECIC 최고역사사용량 | leave_on | ≤ 2.5% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 00975 (2025) |
| 중국 IECIC 최고역사사용량 | rinse_off | ≤ 0.5% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 00975 (2025) |
Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조
Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드
| 제형군 분류 | Min – Q1 – Median – Q3 – Max (%) | 처방 역할 및 기전 | Source ID |
|---|---|---|---|
| 제형군 C — 세정 워시오프 · 폼 · 샴푸 · 바디워시 | 0.15% · 0.25% · 0.4% · 0.5% · 1% | 약산성 클렌저·샴푸 COSMOS 인증 유기산 보존제 | EU Annex V #1 & CIR Benzoic Acid Assessment |
| 제형군 A — 수성 토너 · 세럼 · 고농축 앰플 | 0.1% · 0.2% · 0.3% · 0.4% · 0.5% | 약산성 토너·미스트 천연 유래 보존제 (리브온 한도 0.5%) | KR/EU Preservative Notice Annex |
| 제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O) | 0.15% · 0.15% · 0.15% · 0.575% · 1% | 유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝 | Global Starter Formulation Library Statistical Distribution (n=7, GRANT 4 · SEPPIC 2 · EVONIK 1) |
| 제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션 | 0.15% · 0.15% · 0.15% · 0.1875% · 5% | 선케어·색조 메이크업 분산 안정화 및 발림성 조절 | Global Starter Formulation Library Statistical Distribution (n=8, GRANT 7 · SEPPIC 1) |
각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션
단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.
pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동
권장 구간 밖(pH < 3.5 또는 pH > 5.2)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.
최대 80°C 가열 공정에서 열적 안정성이 유지됩니다.
세포·분자 타깃 작용 기전 플로우 다이어그램
권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도
🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.
상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.
학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)
Tier 1 Synthesis이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.
근거 동료심사 학술 논문 (미국 NIH PubMed) (12)
Allergic Contact Dermatitis to Personal Care Products: A Focus on Established and Emerging Allergens [PMID: 42309282 · 2026]
Allergic contact dermatitis (ACD) to personal care products (PCPs) represents a significant and growing clinical challenge, with increasing use of diverse PCPs and their expanding range of ingredients. Common allergenic components include fragrances, botanicals, preservatives, surfactants, emollients, emulsifiers, vitamins, and ultraviolet filters. Patch testing remains the gold standard for diagnosing ACD and identifying causative allergens, but traditional panels often fail to capture emerging PCP-related allergens. This review highlights key established and emerging PCP allergens, such as limonene and linalool hydroperoxides, sodium benzoate, octocrylene, and benzophenone-4. Strategies are discussed to optimize diagnostic accuracy through targeted series and repeated open application tests. Patient education about PCP labeling is paramount when assisting patients with allergen avoidance. Clinicians must balance precise allergen identification with practical management knowledge to improve outcomes in PCP-related ACD.
Design of Antiacne Gel Containing Phloretin [PMID: 42163615 · 2026]
Acne vulgaris is a common and complex skin condition characterised by excess oil production, blocked pores, and inflammatory lesions, such as papules and nodules. While hormonal factors and sebum overproduction are key contributors, the bacterium Staphylococcus aureus has also been recognised as a contributing pathogen. Phloretin, a flavonoid present in plants, like apples, is a promising new compound for acne treatment. Its potential rests in a variety of biological activities beyond merely acting as an antioxidant. Phloretin displays anti-inflammatory and antibacterial properties, which could directly target both the inflammatory response and the bacterial component of acne. These multiple mechanisms of action indicate that a phloretin-based gel could offer a comprehensive solution for managing the condition. Antiacne gels containing varying concentrations of Carbopol and phloretin were prepared and evaluated. Key parameters included physical appearance, viscosity, pH, drug content, in vitro drug release, and antimicrobial activity against Staphylococcus epidermidis. The optimized hydrogel (F4) exhibited a pH of 6.68, viscosity of 35.9 cP, and drug content of 80.9%. In vitro release studies showed a maximum drug release of 75% over 120 minutes. The formulation displayed strong antimicrobial activity with an inhibition zone of 11 mm, comparable to the marketed benzoyl peroxide gel. The gel was also well tolerated, with no signs of skin irritancy. Antiacne gel containing phloretin can be regarded as a more effective treatment for acne. The optimized formulation consisted of phloretin, Carbopol, ethanol, sodium benzoate, PEG 400, propylene glycol, and triethanolamine, showing better results in terms of antimicrobial activity. Phloretin-based gel demonstrated promising antiacne potential, achieving effective drug release and significant antibacterial activity against Staphylococcus epidermidis, while maintaining acceptable physicochemical and dermatological properties.
Preservatives in Leave-On Cosmetics Available on the Dutch Market [PMID: 41638886 · 2026]
Solid Shampoo Is Mostly Not Preserved, in Contrast to Liquid Shampoos Used in Hairdressing-A Market Survey in Four European Countries [PMID: 41560442 · 2026]
Hairdressers are frequently exposed to shampoos, both from neat liquid products and dilutions, often with unprotected hands. Shampoos usually contain preservatives. While the level of preservation is guided by risk assessment based on typical consumer exposure, this will underestimate sensitization risk in hairdressers. Lower exposure or avoidance of preservative-containing hair cosmetic products appears important for primary prevention of work-related allergic contact dermatitis among hairdressers. To assess the preservatives (Annex V of the EU Cosmetics Regulation (EC 1223/2009)) used in solid shampoos, compare these to preservatives present in liquid shampoos for professional use, and determine the presence of ingredients with "antimicrobial" function in solid shampoo. A physical store check and survey of online sales platforms was performed in four European countries in late 2024. Along with product descriptors, the full INCI labelling was recorded from package labels (or corresponding summaries online) and collected in a spreadsheet. The sample included 172 solid shampoos from various retail sources and 259 liquid shampoos from one online marketplace for professional users. Among solid shampoos, preservatives were found in 31.4%; if "antimicrobial" additives are additionally considered, this share increased to 41.3%. Benzyl alcohol (n = 29) and sodium benzoate (n = 18) were the most common preservatives, benzyl benzoate the most common "antimicrobial" (n = 8). By contrast, all liquid shampoos contained (multiple) preservatives. Solid shampoo shows potential to provide a less-allergenic working environment for hairdressers. Practical aspects should next be addressed to contribute to broader use of solid shampoos.
Mint condition? A survey of allergenic ingredients in UK toothpastes [PMID: 41503662 · 2026]
Toothpastes may induce cheilitis, intraoral lichenoid changes and immediate hypersensitivity reactions. There is little published information documenting the range of allergens in toothpastes. In 2024, a survey was conducted of 291 toothpastes sold by 5 of the UK's largest cosmetics suppliers. Labelling quality and ingredients were recorded. Of the 291 toothpastes, 2 (0.7%) had no ingredients list. Of the remaining 289 (99.3%), the mean number of ingredients was 16.6; 286 (99.0%) contained fragrance, often labelled nonspecifically as 'aroma'. Limonene was in 159/289 (55.0%) and menthol-related compounds were in 105/289 (36.3%). The most frequent preservatives were sodium benzoate or benzoic acid (36/289, 12.5%; 11/289, 3.8%). Polyaminopropyl biguanide, banned in cosmetics in 2015, was declared in 3/289 (1.0%). Sodium lauryl sulfate was present in 159/289 (55.0%). Stannous (tin) fluoride, associated with allergic cheilitis, was present in 21/289 (7.3%). Dermatologists should consider exposure to toothpaste allergens when managing patients with cheilitis, oral mucosal symptoms or immediate systemic symptoms associated with toothbrushing.
Sodium Benzoate Induces Fat Accumulation and Reduces Lifespan via the SKN-1/Nrf2 Signaling Pathway: Evidence from the Caenorhabditis elegans Model [PMID: 39519584 · 2024]
Sodium benzoate (SB) is widely used in food products, cosmetics, and medical solutions due to its antimicrobial properties. While it is generally considered safe and has potential neuroprotective benefits, SB has also been linked to adverse effects, including hepatic oxidative stress and inflammation. However, the potential effects of SB on obesity and lifespan remain poorly understood. In this study, we investigated the effects of SB on fat accumulation and lifespan using the nematode Caenorhabditis elegans ( C. elegans ) as a model system. Wild-type worms were exposed to various SB concentrations (0%, 0.0004%, 0.0008%, 0.004%, and 0.1%) and 0.016% glucose as a positive control for 72 h in liquid or on NGM agar plates. Fat accumulation was assessed through the Oil Red O staining, which revealed that SB induced more fat accumulation compared to vehicle control, even at low concentrations, including the dosage of 0.0004%. Lifespan analysis also demonstrated that SB significantly reduced lifespan in wild-type worms, even at low concentrations. Further investigations found that SKN-1 (an Nrf2 homolog) is necessary for SB-induced fat accumulation and lifespan reduction. Moreover, SB inhibited the nuclear localization of SKN-1 under oxidative stress conditions. These findings suggest that SB may induce fat accumulation and reduce lifespan by inhibiting the oxidative stress-mediated SKN-1 signaling pathway.
Zinc abates sodium benzoate -induced testicular dysfunction via upregulation of Nrf2/ HO-1/ Nf-κB signaling and androgen receptor gene [PMID: 39106537 · 2024]
Sodium Benzoate (SB) is used in daily products such as drinks, juices, sauces, oils, ketchup, toothpaste, mouthwashes, cosmetics, dentifrices, and pharmaceutical products. However, SB has been implicated in gonadotoxicity even at a dosage within the safe limit. Zinc (Zn), on the other hand, has been shown to improve various fertility indices. Hence, this study was designed to explore the possible ameliorative effect of Zn on SB-induced testicular toxicity. Animals were randomly divided into control, SB, Zn, and SB+Zn. All treatment lasted for 28 days. SB treatment caused a derangement in reproductive hormone levels, sperm function, and kinematics and a down-regulation of the Androgen receptor (ANDR). Also, a decrease in testicular levels of SOD, CAT, GSH, Nrf2, and HO- 1 activity and an increase in IL-1β, TNF-α, Nf-κB, and Caspase 3 were observed. These SB-induced distortions were ameliorated in SB-treated rats exposed to Zn. Our study suggests that zinc abates SB-induced testicular toxicity by modulating Nrf2/HO-1/ Nf-κB signaling and ANDR upregulation.
Parental sodium benzoate diet induces fat accumulation in offspring via histone H3K9me3 and SKN-1/Nrf2 [PMID: 41551184 · 2026]
Sodium benzoate is a commonly used food preservative and chemical additive with well-established antimicrobial and antifungal activities, and is widely applied in the food, cosmetic, and pharmaceutical industries. Despite its extensive use, increasing evidence has raised concerns regarding its potential adverse effects on metabolic homeostasis, including the induction of oxidative stress, hepatic inflammation, lipid accumulation, and reduced lifespan. However, whether sodium benzoate-induced obesity phenotypes can be transmitted to subsequent generations via epigenetic mechanisms remains largely unexplored. In this study, we used Caenorhabditis elegans as a model organism to investigate whether the high-lipid phenotype induced by sodium benzoate could be inherited epigenetically by offspring. Our results demonstrated that exposure to sodium benzoate led to a high-lipid phenotype that persisted across multiple generations through epigenetic inheritance. Mechanistically, the transcription factor SKN-1 functioned not only as an effector regulating lipid metabolism but also as a key mediator transmitting epigenetic information to progeny. Furthermore, we identified histone H3 lysine 9 trimethylation (H3K9me3) as a critical epigenetic modification underlying this transgenerational effect. Collectively, these findings indicate that sodium benzoate induces heritable lipid accumulation through the SKN-1/Nrf2 signaling pathway, accompanied by a reduction in H3K9me3 levels.
Integrating multi-wavelength HPLC fingerprinting and electrochemical profiling with chemometrics for comprehensive quality assessment of Kangfuxin Liquid [PMID: 41385803 · 2026]
Kangfuxin Liquid (KFX), a complex zoogenic medicine, faces challenges in quality control due to its multi-component nature and batch-to-batch variability. This study presents a novel integrated quality assessment strategy combining Four-wavelength maximization profiling (Four-WMP) HPLC with electrochemical fingerprinting (ECFP) for comprehensive evaluation of KFX. The Four-WMP method integrated chromatographic data from four wavelengths (236, 254, 265, and 280 nm) into a unified fingerprint, significantly enhancing chemical comprehensiveness compared to conventional single-wavelength approaches. Concurrently, ECFP provided unique insights into redox-active properties. Strong correlations were established between chemical fingerprints and antioxidant efficacy through Partial Least Squares (PLS) modeling (R 2 =0.8672, Q 2 =0.789), identifying critical quality markers including protocatechuic acid and adenosine. Substantial inter-manufacturer variation was observed, particularly in sodium benzoate content, highlighting significant quality inconsistencies. This multi-parametric framework provides a holistic and robust paradigm for quality control of KFX and similar complex medicines, effectively bridging chemical composition with bioactive relevance.
Sodium Benzoate Inhibits Osteoblast Differentiation and Accelerates Bone Loss by Regulating the FGF2/p38/RUNX2 Pathway [PMID: 40404584 · 2025]
Sodium benzoate (NaB) is a commonly used food ingredient that is also found in cosmetics and medicines. Previous studies have demonstrated that long-term NaB intake has detrimental effects on human health, while its effects on bone mass remain unknown. In the present study, intragastric NaB administration was found to decrease bone mass and deteriorate bone microstructure in vivo , while prolonged NaB gavage further accelerated bone loss. The in vitro study revealed that NaB inhibited osteoblast differentiation of bone marrow mesenchymal stem cells and MC3T3-E1 cells. Mechanistically, RNA sequencing analysis elucidated that NaB greatly suppressed fibroblast growth factor 2 (FGF2) expression. Further studies revealed that NaB inhibited p38/RUNX2 signaling transduction, which was downstream of FGF2 for modulating osteoblast differentiation. The rescue studies suggested that NaB inhibited RUNX2 expression and osteoblast differentiation through the p38/MAPK signaling pathway. Collectively, NaB accelerated bone loss by inhibiting osteoblast differentiation through downregulating FGF2/p38/RUNX2 signaling pathway. The present study revealed that the long-term intake of NaB-containing food increased the risk of bone loss and osteoporosis (OP). Therefore, a reasonable oral intake of NaB-containing food is an important but convenient initiative for preventing OP.
Development of Alginate Hydrogels Incorporating Essential Oils Loaded in Chitosan Nanoparticles for Biomedical Applications [PMID: 39598707 · 2024]
A hybrid alginate hydrogel-chitosan nanoparticle system suitable for biomedical applications was prepared. Chitosan (CS) was used as a matrix for the encapsulation of lavender ( Lavandula angustifolia ) essential oil (LEO) and Mentha ( Mentha arvensis ) essential oil (MEO). An aqueous solution of an acidic Natural Deep Eutectic Solvent (NADES), namely choline chloride/ascorbic acid in a 2:1 molar ratio, was used to achieve the acidic environment for the dissolution of chitosan and also played the role of the ionic gelator for the preparation of the chitosan nanoparticles (CS-NPs). The hydrodynamic diameter of the CS-MEO NPs was 130.7 nm, and the size of the CS-LEO NPs was 143.4 nm (as determined using Nanoparticle Tracking Analysis). The CS-NPs were incorporated into alginate hydrogels crosslinked with CaCl 2 . The hydrogels showed significant water retention capacity (>80%) even after the swollen sample was kept in the aqueous HCl solution (pH 1.2) for 4 h, indicating a good stability of the network. The hydrogels were tested (a) for their ability to absorb dietary lipids and (b) for their antimicrobial activity against Gram-positive and Gram-negative foodborne pathogens. The antimicrobial activity of the hybrid hydrogels was comparable to that of the widely used food preservative sodium benzoate 5% w / v .
Cocaine(Archived) [PMID: 28613520 · 2026]
자주 묻는 질문 (AEO 스니펫 최적화 FAQ)
- Q1. 소듐벤조에이트 (SODIUM BENZOATE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
- 한국 식약처 표준명은 '소듐벤조에이트', 미국 PCPC 및 유럽 CosIng INCI 표기는 'SODIUM BENZOATE', 중국 NMPA IECIC 표준명은 '苯甲酸钠', 일본 화장품 표시명칭은 '安息香酸Na'입니다.
- Q2. 소듐벤조에이트의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
- 한국(KR: restricted), 유럽(EU: restricted), 미국(US: none), 중국(CN: restricted), 일본(JP: none), 아세안(ASEAN: restricted) 고시 기준을 준수하여 처방해야 합니다.
- Q3. 제형 설계 시 소듐벤조에이트의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
- 대표 제형군(cleanser_rinse) 기준 통상 0.15~1%(권장 중앙값 0.4%) 범위로 투입하며, 적정 pH는 3.5~5.2입니다.
- Q4. 소듐벤조에이트 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
- 주요 권장 시너지 조합은 POTASSIUM SORBATE, CITRIC ACID, GLUCONOLACTONE, XANTHAN GUM이며, 배합 주의사항은 pH 5.5 초과 시 비해리 벤조익애씨드 분율이 급감하여 방부력이 완전히 상실됨 (반드시 pH 4.0~5.2 유지!); 강한 1가 전해질이므로 카보머(Carbomer) 점도를 즉각 무너뜨림; 순수 비타민C(Ascorbic Acid) + 금속이온 + 자외선 공존 시 극미량 벤젠(Benzene) 환원 우려가 있으므로 비타민C 처방에 배합 금기입니다.